Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study

January 22, 2024 updated by: Mohamed Hussein, Fayoum University

The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole.

The main questions it aims to answer are:

  • What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery.
  • Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively.
  • What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap.

Participants will be:

  • Subjected to pars plana vitrectomy to repair macular hole.
  • Examined by optical coherence tomography angiography pre and post operative

Researchers will compare:

Group A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will include 28 eyes with idiopathic full thickness macular hole; they will be divided into two groups:

Group A: 14 eyes will be treated without ILM flap Group B : 14 eyes will be treated by ILM flap

  • Sample size: 28 eyes. (based on ELM recovery rate in ILM flap 70% versus 21.4% with inverted flap (Iwasaki et al., 2019), and at power of study 80% and confidence level 95%, sample size is calculated using openEpi software to be 14 eyes in each group
  • Study setting: Ophthalmology Department, Fayoum University and the Research Institute of Ophthalmology

  • Data Collection :

    • History :

      1. Demographic data ( age , gender )
      2. General medical history ( DM, HTN )
      3. Symptom duration
      4. Previous ocular history

    • Clinical examination:

      1. Best corrected visual acuity using snellen chart (converted to log MAR for statiscal analysis).
      2. Slit lamp biomicroscopy for anterior segment examination.
      3. Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
      4. Axial length measurement
    • Optical Coherence Tomography:

We use SD- OCT and OCTA for pre and post-operative evaluation of retinal layers microstructure and vasculature.

  • Surgical Procedure

All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:

  • 23 G trocar system will be used
  • Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done
  • Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling

Patients will be divided then into two groups:

Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done

  • Shaving of the vitreous base, and then fluid air exchange

  • SF 6 gas tamponade will be used

    • Study procedures:

    o Regular clinical assessment pre and at 1 and 6 months post-operative including:

  • Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis

  • Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)

    • Standard Optical coherence tomography of the macula at 1 and 6 months post-operative using (SD-OCT) scans (512 A-scans, 20°×20°) with the following protocol:

Macula thickness map for measurement of central retinal thickness, and photoreceptor inner segment/outer segment complex.

o Optical coherence tomography angiography of the macula at 1 and 6 months post-operative studying Superficial Capillary plexus, Deep Capillary plexus and Fovea avascular zone.

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt, 12511
        • Recruiting
        • research institute of ophthalmology, Egypt
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Idiopathic full thickness Macular hole without retinal detachment

Exclusion Criteria:

  • Previous pars plana vitrectomy
  • High myopia with axial length ≥ 26 mm.
  • Uncertain symptom duration or ≥ 6 month .
  • History of same eye trauma
  • Poor image quality.
  • Patients with diabetic retinopathy or other retinal diseases, e.g. ischemic, inflammatory.
  • Any patient with significant cataract which needs combined phaco-vitrectomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: eyes will be treated without ILM flap
Group A: Only wide ILM peeling up to the arcades well be done
Procedure: pars plana vitrectomy

All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:

  • 23 G trocar system will be used
  • Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done
  • Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling

Patients will be divided then into two groups:

Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done

  • Shaving of the vitreous base, and then fluid air exchange
  • SF 6 gas tamponade will be used
Other Names:
  • PPV with ILM peeling
Active Comparator: Group B : eyes will be treated by ILM flap
Group B: ILM peeling with flap well be done
Procedure: pars plana vitrectomy

All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:

  • 23 G trocar system will be used
  • Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done
  • Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling

Patients will be divided then into two groups:

Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done

  • Shaving of the vitreous base, and then fluid air exchange
  • SF 6 gas tamponade will be used
Other Names:
  • PPV with ILM peeling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: It will be measured preoperative and at 1 and 6 months post-operative
Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
It will be measured preoperative and at 1 and 6 months post-operative
Fovea avascular zone FAZ
Time Frame: It will be measured preoperative and at 1 and 6 months post-operative
Optical coherence tomography angiography used to measure FAZ area in mm2 (mm square)
It will be measured preoperative and at 1 and 6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central retinal thickness
Time Frame: It will be measured preoperative and at 1 and 6 months post-operative
Standard Optical coherence tomography of the macula using (SD-OCT) scans (512 A-scans, 20°×20°) to measure central retinal thickness in µm
It will be measured preoperative and at 1 and 6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Collaborators

Research Institute of Ophthalmology, Egypt

Investigators

  • Study Director: Islam Mohalhal, MD, research institute of ophthalmology, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Estimated)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FayoumU_28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD that underlie results in a publication

IPD Sharing Time Frame

data will become available before the end of 2024 and will be available for 1 year

IPD Sharing Access Criteria

it will be shared via E-mail

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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